Neoadjuvant Intra-tumoral RP2 and FLOT in Gastroesophageal Adenocarcinoma

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

November 8, 2025

Primary Completion Date

November 1, 2027

Study Completion Date

November 1, 2029

Conditions
Gastric AdenocarcinomaEsophageal AdenocarcinomaGastroesophageal Junction Adenocarcinoma
Interventions
BIOLOGICAL

RP2

Upper endoscopy with RP2 intra-tumoral injection of 1 x 10(6) plaque forming units (PFU)/mL for first intra-tumoral injection, up to 10mL of 1x107 PFU/mL of RP2 for subsequent intra-tumoral injections. Injection will occur within 4 days prior of each cycle FLOT.

COMBINATION_PRODUCT

5-Fluorouracil

5-Fluorouracil as part of the FLOT regimen 2,600mg/m2 intravenous infusion over 24 hours on day 1 of each 14-day cycle for 4 cycles.

COMBINATION_PRODUCT

Leucovorin

Leucovorin as part of the FLOT regimen 200mg/m2 intravenous infusion on day 1 of a 14-day cycle for 4 cycles.

COMBINATION_PRODUCT

Oxaliplatin

Oxaliplatin as part of the FLOT regimen 85mg/m2 intravenous infusion on day 1 of a 14-day cycle for 4 cycles.

COMBINATION_PRODUCT

Docetaxel

Docetaxel as part of the FLOT regimen 50mg/m2 intravenous infusion on day 1 of a 14-day cycle for 4 cycles.

DRUG

Pegfilgrastim

Pegfilgrastim or Filgrastim is required on the study and should be administered per the package insert of the commercially obtained drug following each cycle of FLOT for 4 cycles.

DRUG

Filgrastim

Filgrastim or Pegfilgrastim is required on the study and should be administered per the package insert of the commercially obtained drug following each cycle of FLOT for 4 cycles.

PROCEDURE

Surgical Resection of Primary Tumor

Following 4 cycles of preoperative FLOT with RP2 injections, surgical resection of esophageal, GEJ, or gastric primary tumor per standard of care practice.

Trial Locations (1)

19104

Abramson Cancer Center at the University of Pennsylvania, Philadelphia

All Listed Sponsors
collaborator

Replimune Inc.

INDUSTRY

lead

Abramson Cancer Center at Penn Medicine

OTHER